Clinical Site Manager

hace 1 mes


Xico, México Novasyte A tiempo completo

Job Overview

We are seeking a skilled Clinical Site Manager to join our team at Novasyte. This role offers an exciting opportunity to utilize your clinical research expertise and take on a challenging position that involves managing site monitoring activities.

About the Role:

This position will be responsible for performing site monitoring visits, administering protocol training to assigned sites, and evaluating site practices related to the proper conduct of clinical trials. Additionally, you will track regulatory submissions and approvals, manage study progress, ensure accurate documentation, and collaborate with the study team to support project execution.

Responsibilities:

  • Perform site monitoring visits in accordance with contracted scope of work and regulatory requirements.
  • Administer protocol training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues.
  • Evaluate site practices and adherence to regulations, escalating quality issues as necessary.
  • Track regulatory submissions and approvals, case report form completion, data query generation, and resolution.
  • Manage the Investigator's Site File (ISF) in accordance with Good Clinical Practice (GCP) and local regulatory requirements.
  • Create and maintain documentation regarding site management, monitoring visit findings, and action plans.
  • Mentor clinical staff through co-monitoring and training visits.

Requirements:

To be successful in this role, you should have a Bachelor's Degree in a scientific discipline or healthcare, along with at least 3 years of on-site monitoring experience. You should also possess in-depth knowledge of clinical research regulatory requirements and strong therapeutic and protocol knowledge.

What We Offer:

In exchange for your expertise, we offer a competitive salary of approximately $90,000 per year, depending on location, along with opportunities for professional growth and development within our organization.



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